Clinical Research Scientist

Job Responsibilities

The Clinical Research Associate/Scientist will be responsible for:

1. Scoping

• Help the team in rapid and accurate feasibility analysis of

upcoming projects. Example projects are in the areas of

Oncology, Reproductive health, metabolic disorders,

neurodegenerative diseases etc often involving some

genomics component to the study design,

• This involves engaging with investigators across the country,

and getting reasonably accurate estimates of recruitment rates,

often for difficult indications.

2. Planning and Setup

• Contribute in planning and setting up of new clinical studies

including drafting/refining the study related documents and EC

dossiers,

• Identify candidate sites and engage with PIs and site CRCs to

assess feasibility for shortlisting sites, negotiate with sites to

draft agreements for engagement,

• Put together necessary documentation for EC submissions and

assist site teams as needed to ensure EC approvals are

obtained in a timely manner

• Regular and prompt performing quality control (QC) checks on

clinical data received. This involves reviewing the data for

accuracy, consistency, and completeness, ensuring that all

entries are correctly documented and any discrepancies or

errors are identified and addressed in a timely manner.

Collaborate with other team members to resolve any issues

and ensure compliance with regulatory requirements.

• Plan the setup of other systems and processes for the smooth

running of the trial including where needed setup of systems

such as IVRS/IWRS, EDC for electronic CRFs, drafting of

study documents, ISF etc. and take care of site initiation

activities.

• Put together the necessary documentation for regulatory

compliance submissions like DCGI/CTRI/HMSC etc.,

• Manage vendors, contracts and sourcing and help in budgeting

and meticulous planning of projects to ensure smooth

implementation and execution of the studies.

3. Implementation & Execution

• Implement processes for efficient conduct of clinical

projects/trials,

• Take care of necessary activities for training of site staffs and

conducting the Site Initiation,

• Ensure that for each study, each site, each subject the data

collection, data validation and monitoring is diligently done,

• Troubleshoot issues faced in clinical studies in a timely manner

like recruitment of subjects using innovative ideas like putting

in place systems to rigorously screen patients in OPDs, setting

up referral networks with hospitals having substantial patient

load, and working with investigators with different ideas for

recruitment,

• Ensure adherence to GCP guidelines to carry out high quality

clinical studies following good ethical practices,

• Ensure smooth handling and reporting of SAEs, payments of

medical expenses, compensation, etc keeping record of the

same for audit purpose,

• Track and update status of the studies, identify challenges,

record issues with issue resolution matrix and discuss potential

solutions in internal meetings, customer meetings etc.,

• Manage the costs and timelines of implementation in line with

the original proposal for the project

• Ensure that SOPs for the clinical studies are up-to-date and

work with relevant team members for conducting the study in

accordance with the SOP

• Ensure proper training of new team members, take care of

documentation and records for sponsor audits, regulatory

inspections and ensure that all the study records are

diligently maintained for posterity

Candidates Requirements

• Ph.D. degree in life sciences, fresher or with an experience of 1-2

years in oncology or clinical trials management

• Ability to successfully manage/work simultaneous trials and meet

deadlines

• Clinical Data Management experience preferably as part of a CRO

team in more than one therapeutic area would be an advantage

• Excellent understanding of clinical trials methodology, GCP (Good

Clinical Practice), GDMP (Good clinical data management practice)

and medical terminology

• Have comprehensive knowledge of clinical guidelines like NDCT

(New Drugs and Clinical Trials) rules, ICMR guidelines, DCA (Drugs

and Cosmetics Act) and procedures involved with relevant Govt

regulatory bodies is desirable and will be an added advantage

• Good organizational skills as the job profile involves lot of

documentation and recording of information through computerized

processes of clinical trial management systems and electronic data

capture

• High attention to details and a strong analytical mind set
• Demonstrates comprehensive knowledge of capturing and storing

clinical information

• Excellent proficiency in English language
• Demonstrated experience of working in multicultural and

multidisciplinary environments

• Dynamic team player with excellent communication and networking

skills, flexible mindset and scientifically curious

• Willing to travel within city and outside as required (job demands 50%

or travel and may require extended period of stay at a site location

based on project need)